oracle argus cloud services service descriptions and metrics

Oracle Argus Cloud Service – Service Descriptions of 35

Oracle Health Sciences

Oracle Argus Cloud Service

Service Descriptions and Metrics

18-October-2021


TABLE OF CONTENTS

Metric Definitions 3

Case – Pooled Capacity 3

Japan Case – Pooled Capacity 3

Instance 3

Glossary 3

Non-Production Environment 3

Production Environment 4

Service Descriptions 5

Oracle Argus Advanced Cloud Service, Base - Instance 5

Oracle Argus Advanced Cloud Service, Case – Case - Pooled Capacity 8

Oracle Argus Advanced Cloud Service, Japan Case – Japan Case - Pooled Capacity 9

Oracle Argus Advanced Cloud Service, Additional Non-Production Environment – Instance 9

Oracle Argus Advanced Cloud Service, Data Replication – Instance 10

Oracle Argus Advanced Cloud Service, Data Replication, Additional Non-Production Environment –

Instance 11

Oracle Argus Basic Cloud Service, Base – Instance 12

Oracle Argus Basic Cloud Service, Case – Case - Pooled Capacity 15

Oracle Argus Basic Cloud Service, Japan Case – Japan Case - Pooled Capacity 16

Oracle Argus Basic Cloud Service, Additional Non-Production Environment – Instance 16

Retired Offerings 18

DEFINITIONS FOR RETIRED OFFERINGS 18

Case 18

SERVICE DESCRIPTIONS FOR RETIRED OFFERINGS 18

Oracle Argus Enterprise Edition Cloud Service – Case 18

Oracle Argus Safety Japan Enterprise Edition Cloud Service – Case 21

Oracle Argus Enterprise Edition Enhanced Disaster Recovery Cloud Service – Case 22

Oracle Argus Enterprise Edition Cloud Service Additional Non-Production Environment – Instance 23

Oracle Argus Enterprise Edition Data Replication Cloud Service – Instance 24

Oracle Argus Enterprise Edition Data Replication Cloud Service Additional Non-Production

Environment – Instance 25

Oracle Argus Standard Edition Cloud Service – Case 25

Oracle Argus Safety Japan Standard Edition Cloud Service – Case 28

Oracle Argus Standard Edition Enhanced Disaster Recovery Cloud Service – Case 30

Oracle Argus Standard Edition Cloud Service Additional Non-Production Environment – Instance 30

Oracle Argus Standard Edition Data Replication Cloud Service – Instance 31

Oracle Argus Standard Edition Data Replication Cloud Service Additional Non-Production

Environment – Instance 32

Oracle Argus Cloud Service Additional Non-Production Environment – Instance 33

Oracle Argus Cloud Service Enhanced Disaster Recovery – Instance 33

Oracle Argus Safety Japan Cloud Service – Case 34


METRIC DEFINITIONS

Case – Pooled Capacity

“Case” is defined as a record in the Cloud Service, identified by a case ID number, which contains data

elements related to the safety of a product. A Case does not include Oracle Argus features in Japanese

language.

“Case – Pooled Capacity” means the quantity of Cases purchased will be made available as a pool of

Cases which may be used during the term of the Services Period. Each Case used is deducted from the

available pool of Cases. A Case is “used” when it is created in the Cloud Service, including but not

limited to Cases identified as “E2B”, “Deleted”, and “Literature” Cases. Notwithstanding the preceding

sentence, Cases migrated into the Cloud Services do not count toward the quantity of Cases used. Any

unused Cases expire at the end of the Services Period and do not carry over to subsequent Services

Periods.

Japan Case – Pooled Capacity

“Japan Case” is defined as a record in the Cloud Service, identified by a case ID number, which contains

data elements related to the safety of a product and uses Oracle Argus pages and/or data items in

Japanese language. A Japanese Case may originate from any region worldwide and is used in

assessment and/or submission to PMDA (Pharmaceuticals and Medical Devices Agency).

“Japan Case – Pooled Capacity” means the quantity of Japan Cases purchased will be made available

as a pool of Japan Cases which may be used during the term of the Services Period. Each Japan Case

used is deducted from the available pool of Japan Cases. A Japan Case is “used” when it is created in

the Cloud Service, including but not limited to Cases identified as “E2B”, “Deleted”, and “Literature”

Cases. Notwithstanding the preceding sentence, Japan Cases migrated into the Cloud Services do not

count toward the quantity of Japan Cases used. Any unused Japan Cases expire at the end of the

Services Period and do not carry over to subsequent Services Periods.

Instance

Instance is defined as single deployment of the application. For details of deployment specific to the

application please refer to service descriptions/entitlements.

GLOSSARY

Non-Production Environment

Non-Production Environment may be either a Test or Development Environment provided to You as

part of the Cloud Services. The Non-Production Environment(s) are specifically sized and designed

for development and training purposes and may not be used for production purposes or for

performance or stress testing. Any service levels, performance targets and disaster recovery

described for the applicable Oracle Cloud Service are not applicable to Non-Production Environments.


Production Environment

Production Environment is defined as the environment provided to You as part of the Oracle Cloud

Service that is designed for daily commercial use and production operations of live data. Unless

otherwise specified, a single Production Environment is provided for an Oracle Cloud Service.


SERVICE DESCRIPTIONS

Oracle Argus Advanced Cloud Service, Base - Instance

Part #: B93361

Modules and Features

Users of the Oracle Argus Advanced Cloud Service, Base are authorized to access the following

modules:

Oracle Argus Safety

Oracle Argus Affiliate

Oracle Argus Interchange

Oracle Argus Dossier

Oracle Argus Insight

Oracle Argus Analytics

Oracle Argus Mart

Oracle B2B

Usage Limits

The Cloud Service is subject to usage limits based on:

The quantity of Instances defined in your order.

Oracle will provision one (1) Production Environment and two (2) Non-Production

Environments for each Instance you have ordered.

The Cloud Service provides 2 node RAC database and web servers. These are load

balanced to provide a high availability solution in the event of a failure on the primary

servers.

Up to 5 terabytes per database instance.

Service Level Targets

The Cloud Service has the following service level targets:

CLOUD SERVICE RECOVERY TIME

OBJECTIVE (RTO)

RECOVERY POINT

OBJECTIVE (RPO)

TARGET SYSTEM

AVAILABILITY

Oracle Argus Advanced Cloud Service,

Base 24 Hours 1 Hour 99.5%

The Service Level Targets do not apply to the Non Production Environment(s). For the purposes of

this Cloud Service, the Service Level Targets above take precedence over anything to the contrary

in the Oracle Cloud Policies.

Third Party License Requirements:

Oracle Argus Interchange module, used with an electronic gateway, enables electronic submissions

Oracle Argus Cloud Service – Service Descriptions

and exchanges. The Oracle B2B gateway is supported as an option for the electronic gateway.

Oracle Argus Interchange module can also be used along with Axway B2Bi for electronic

submission. Axway B2Bi is required as the electronic gateway for Partition Mode, as described

below. The permitted exchange protocols are AS1 and AS2 with message encryption and/or

HTTPS-enabled transmission. For AS1 communication, configuration of IMAP/POP3 is supported

using SMTP over VPN.

For Oracle to provide the Oracle Argus Cloud Service, You are required to obtain the necessary

licenses to any of the following third party software You will use:

Axway B2Bi 2.6 SP1

JDrug

MedDRA/MedDRA J Dictionaries

Microsoft Office

RightFax 10.6 (32-bit) (subject to the limitations below)

WHO Drug Dictionary

Third Party Software Limitations:

Documentum is not supported for Oracle Argus Cloud Service.

Use of RightFax with Oracle Argus Cloud Service is partially enabled. For faxing from Oracle

Argus Cloud Service, fax via email using Your fax as the end point. Fax status tracking and

fax responses are not available in Oracle Argus Cloud Service.

For any required third party software You will use, You must purchase a license, as well as all

consents, permits, and authorizations necessary for Oracle to access and use this software on Your

behalf directly from such third parties as part of this offering. You must provide evidence of such

licenses prior to Oracle’s installation of such, as well as a copy of the licensed software if applicable,

and You are responsible for supporting such software (including the purchase of support contracts

from the third party vendors as applicable).

For Axway B2Bi, You must provide Oracle with Your Axway “Support Identifier”. You will permit

Oracle to use your Axway Support Identifier to file service requests with Axway. You will provide

the assistance necessary for Oracle to pursue and escalate any issues and requests with Axway as

needed to attempt to resolve issues impacting Your ability to use the Services; however, You are

ultimately responsible for support of the Axway software.

Use of the Oracle Argus Cloud Service offering is subject to certain expectations and requirements

regarding the following 3rd party software:

1. To use MedDRA within the Oracle Argus Cloud Service, You will work with Oracle to

establish the necessary private circuit or VPN solution to facilitate secure web service

communications between the Oracle servers and Your network. You will be required to

have an authentication mechanism in place to secure the web service communication.

2. To use the SMTP capabilities from within the Argus Cloud Service, You must host within

Your network the required SMTP server necessary for these capabilities, and the SMTP

service must be accessible to the Oracle servers over a private circuit or VPN line.

3. Any digital certificates provided by You to Oracle for the purpose of system integrations


must be issued by a commercial certificate authority.

The services listed below require a separate service engagement with Oracle to define, configure/

implement, test, and deploy:

Any data migration between versions

Customer-specific migration services required for transformation of Your data to Oracle

data models

All services not listed in this services description

Use of Utilities:

The Cloud Service may include access to certain Oracle Argus utilities, which is subject to Your

Responsibilities set forth below.

Argus Cloud Extensibility and Integrations Utility

Oracle Responsibilities:

Upon Your request, deploy Your customizations or extensions in Your Non-Production

Environment(s) in accordance with Your Installation Documentation (as defined below).

Upon Your confirmation that You have validated the customizations or extensions in Your Non-

Production Environment(s), deploy the customizations or extensions in Your Production

Environment in accordance with Your Installation Documentation.

Provide You with 30 calendar days’ notice prior to upgrading the base application code version in

Your Environment(s).

Your Responsibilities:

Develop Your own customizations or extensions using the Argus Cloud Extensibility and

Integrations Utility in accordance with Oracle’s extensibility guidelines, which are available at

support.oracle.com (Doc ID 2399180.1). You are responsible for the quality of Your customization

or extension code and ensuring that secure coding practices are followed.

Submit to Oracle change management requests to add customizations or extensions to Your

Non-Production and Production Environments, which must include:

o Argus Cloud Extensibility checklist (available at support.oracle.com, Doc ID 2399180.1).

o Clear, concise, and accurate documentation detailing installation steps for Your

customizations or extensions in the Non-Production and Production Environments of the

Cloud Service (“Your Installation Documentation”)

o Installation script

Review and validate customizations or extensions in Your Non-Production Environment(s) before

the customizations or extensions may be deployed in Your Production Environment and, upon

request by Oracle, confirm within 30 calendar days that You have validated Your customizations

or extensions and that they may be deployed in Your Production Environment.

You are solely responsible for Your customizations or extensions created using the Argus Cloud

Extensibility and Integrations Utility, including without limitation:


o Validating and resolving issues related to any impacts of maintenance or change

management (including but not limited to patches, upgrades, or new releases) on Your

customizations or extensions.

o Changes to customizations and extensions to ensure compatibility with the Cloud

Services.

Oracle reserves the right to disable such customizations and extensions if you do not validate or

resolve issues in an agreed to timeframe and/ or Oracle believes in its discretion that the

customizations and extensions pose issues and/ or risks to its services.

Oracle Cloud Policies

The Services are subject to the Oracle Cloud Hosting and Delivery Policies and Oracle Global

Business Unit Cloud Services Pillar Document, which may be viewed at www.oracle.com/contracts.

Oracle Argus Advanced Cloud Service, Case – Case - Pooled Capacity

Part #: B93362

Users of this Cloud Service are authorized to access the following modules:

Oracle Argus Advanced Cloud Service, Base

Usage Limits: The Cloud Service is subject to usage limits based on:

The quantity of Cases - Pooled Capacity defined in Your order

A combined maximum of 500,000 Cases and Japan Cases may be used (as defined

above) during the Services Period. If You require more than 500,000 then You may need

to place an additional order for Oracle Argus Advanced Cloud Service.

The Oracle Argus Advanced Cloud Service, Base is a prerequisite for this Cloud Service.

This Cloud Service is subject to the Usage Limits for Oracle Argus Advanced Cloud

Service, Base.

Service Level Targets:

The Service Level Targets for this Oracle Cloud Service are provided with the Oracle Argus

Advanced Cloud Service, Base.

Oracle Cloud Policies:



http://www.oracle.com/contracts



Oracle Argus Advanced Cloud Service, Japan Case – Japan Case - Pooled Capacity

Part #: B93363


Users of the Oracle Argus Advanced Cloud Service, Japan Case are authorized to access the

following modules:


Oracle Argus Safety Japan

Usage Limits


The quantity of Japan Cases - Pooled Capacity defined in your order.

A maximum of 500,000 Cases and Japan Cases may be used (as defined above) during

the Services Period. If You require more than 500,000 then You may need to place an

additional order for Oracle Argus Advanced Cloud Service.

The Oracle Argus Advanced Cloud Service, Base is a prerequisite for this Cloud Service.

This Cloud Service is subject to the Usage Limits for Oracle Argus Advanced Cloud

Service, Base.


The Service Level Targets for this Oracle Cloud Service are provided with the Oracle Argus

Advanced Cloud Service, Base.




Oracle Argus Advanced Cloud Service, Additional Non-Production Environment –

Instance

Part #: B93364


Oracle Argus Advanced Cloud Service, Additional Non-Production Environment is provided for the

following modules:

Oracle Argus Advanced Cloud Service

Usage Limits

The Additional Non-Production Environment is subject to usage limits based on:




Limited to use for Your Oracle Argus Advanced Cloud Service.

Oracle will provision one (1) Non-Production Environment for each Instance You have

ordered.

Certain programs and optional services may not be able to run in the Additional Non-

Production Environment.

The maintenance or upgrade schedule for the Additional Non-Production Environment is

the same as the schedule for Your Production Environment.


The Service Level Targets applicable to Your Production Environment(s), including Target System

Availability, are not applicable to the Additional Non-Production Environment.




Oracle Argus Advanced Cloud Service, Data Replication – Instance

Part #: B93365


Oracle Argus Advanced Data Replication Cloud Service is provided for the following modules that

You have purchased:


Oracle Argus Advanced Cloud Service, Case

Oracle Argus Advanced Cloud Service, Japan Case

Setup

Setup includes configuration of the source database for this Cloud Service.

Usage Limits



Oracle will provision one (1) Production Environment for each Instance You have ordered.

The maintenance or upgrade schedule for the Oracle Argus Advanced Cloud Service, Data

Replication is the same as the schedule for Your Oracle Argus Advanced Cloud Service.






OBJECTIVE (RTO)

RECOVERY POINT

OBJECTIVE (RPO)

TARGET SYSTEM

AVAILABILITY

Oracle Argus Advanced Cloud Service,

Data Replication 24 Hours 1 Hour 99.5%

The Service Level Targets do not apply to the Non Production Environment(s). For the purposes of

this Cloud Service, the Service Level Targets above take precedence over anything to the contrary

in the Oracle Cloud Policies.




Oracle Argus Advanced Cloud Service, Data Replication, Additional Non-Production

Environment – Instance

Part #: B93366


Oracle Argus Advanced Cloud Service, Data Replication, Additional Non-Production Environment

is provided for the following modules that You have purchased:


Oracle Argus Advanced Cloud Service, Case

Oracle Argus Advanced Cloud Service, Japan Case

Setup

Setup includes configuration of the source database for this Cloud Service.

Usage Limits




ordered.

The maintenance or upgrade schedule for the Oracle Argus Advanced Cloud Service, Data

Replication, Additional Non-Production Environment is the same as the schedule for Your

Oracle Argus Advanced Cloud Service.



Availability, are not applicable to the Additional Non-Production Environment. Disaster Recovery

is not available for the Additional Non-Production Environment.






Oracle Argus Basic Cloud Service, Base – Instance

Part #: B93357


Users of Oracle Argus Basic Cloud Service, Base are authorized to use the following modules:

Oracle Argus Safety




Oracle B2B

Usage Limits



Oracle will provision one (1) Production Environment and two (2) Non-Production

Environments for each Instance You have ordered.

The Cloud Service provides 2 node RAC database and web servers. These are load

balanced to provide a high availability solution in the event of a failure on the primary

servers.

Up to 5 terabytes per database instance.




OBJECTIVE (RTO)

RECOVERY POINT

OBJECTIVE (RPO)

TARGET SYSTEM

AVAILABILITY

Oracle Argus Basic Cloud Service, Base 30 to 90 days 48 Hours 99.5%

The Service Level Targets do not apply to the Non Production Environment(s). The Target System

Availability does not apply in the event of a declared disaster. For the purposes of this Cloud

Service, the Service Level Targets above take precedence over anything to the contrary in the

Oracle Cloud Policies.


Oracle Argus Interchange module, used with an electronic gateway, enables electronic submissions

and exchanges. The Oracle B2B gateway is supported as an option for the electronic gateway.

Oracle Argus Interchange module can also be used along with Axway B2Bi for electronic



submission. Axway B2Bi is required as the electronic gateway for Partition Mode, as described

below. The permitted exchange protocols are AS1 and AS2 with message encryption and/or

HTTPS-enabled transmission. For AS1 communication, configuration of IMAP/POP3 is supported

using SMTP over VPN.

For Oracle to provide the Oracle Argus Cloud Service, You are required to obtain the necessary

licenses to any of the following third party software You will use:

Axway B2Bi 2.6 SP1

JDrug


Microsoft Office


WHO Drug Dictionary




Argus Cloud Service, fax via email using Your fax as the end point. Fax status tracking and

fax responses are not available in Oracle Argus Cloud Service.

For any required third party software You will use, You must purchase a license, as well as all

consents, permits, and authorizations necessary for Oracle to access and use this software on Your

behalf directly from such third parties as part of this offering. You must provide evidence of such

licenses prior to Oracle’s installation of such, as well as a copy of the licensed software if applicable,

and You are responsible for supporting such software (including the purchase of support contracts

from the third party vendors as applicable).

For Axway B2Bi, You must provide Oracle with Your Axway “Support Identifier”. You will permit

Oracle to use your Axway Support Identifier to file service requests with Axway. You will provide

the assistance necessary for Oracle to pursue and escalate any issues and requests with Axway as

needed to attempt to resolve issues impacting Your ability to use the Services; however, You are

ultimately responsible for support of the Axway software.



1. To use MedDRA within the Oracle Argus Cloud Service, You will work with Oracle to

establish the necessary private circuit or VPN solution to facilitate secure web service

communications between the Oracle servers and Your network. You will be required to

have an authentication mechanism in place to secure the web service communication.

2. To use the SMTP capabilities from within the Argus Cloud Service, You must host within

Your network the required SMTP server necessary for these capabilities, and the SMTP

service must be accessible to the Oracle servers over a private circuit or VPN line.

3. Any digital certificates provided by You to Oracle for the purpose of system integrations

must be issued by a commercial certificate authority.





Customer-specific migration services required for transformation of Your data to Oracle

data models


Use of Utilities:








Production Environment(s), deploy the customizations or extensions in Your Production

Environment in accordance with Your Installation Documentation.




Develop Your own customizations or extensions using the Argus Cloud Extensibility and

Integrations Utility in accordance with Oracle’s extensibility guidelines, which are available at

support.oracle.com (Doc ID 2399180.1). You are responsible for the quality of Your customization

or extension code and ensuring that secure coding practices are followed.

Submit to Oracle change management requests to add customizations or extensions to Your

Non-Production and Production Environments, which must include:






Review and validate customizations or extensions in Your Non-Production Environment(s) before

the customizations or extensions may be deployed in Your Production Environment and, upon

request by Oracle, confirm within 30 calendar days that You have validated Your customizations

or extensions and that they may be deployed in Your Production Environment.



o Validating and resolving issues related to any impacts of maintenance or change


management (including but not limited to patches, upgrades, or new releases) on Your

customizations or extensions.

o Changes to customizations and extensions to ensure compatibility with the Cloud

Services.







Oracle Argus Basic Cloud Service, Case – Case - Pooled Capacity

Part #: B93358

Users of this Cloud Service are authorized to access the following modules:

Oracle Argus Basic Cloud Service, Base

Usage Limits: The Cloud Service is subject to usage limits based on:

The quantity of Cases - Pooled Capacity defined in Your order

A combined maximum of 20,000 Cases and Japan Cases may be used (as defined above)

during the Services Period (including the quantity purchased on the initial order and any

subsequent orders expanding the quantity). If You require more than 20,000 then You

may be required to upgrade to Oracle Argus Advanced Cloud Service.

The Oracle Argus Basic Cloud Service, Base is a prerequisite for this Cloud Service.

This Cloud Service is subject to the Usage Limits for Oracle Argus Basic Cloud Service,

Base.


The Service Level Targets for this Oracle Cloud Service are provided with the Oracle Argus Basic

Cloud Service, Base.







Oracle Argus Basic Cloud Service, Japan Case – Japan Case - Pooled Capacity

Part #: B93359


Users of the Oracle Argus Basic Cloud Service, Japan Case are authorized to access the following

modules:

Oracle Argus Basic Cloud Service, Base


Usage Limits


The quantity of Cases - Pooled Capacity defined in your order.

A combined maximum of 20,000 Cases and Japan Cases may be used (as defined above)

during the Services Period (including the quantity purchased on the initial order and any

subsequent orders expanding the quantity). If You require more than 20,000 then You

may be required to upgrade to Oracle Argus Advanced Cloud Service.

The Oracle Argus Basic Cloud Service, Base is a prerequisite for this Cloud Service.

This Cloud Service is subject to the Usage Limits for Oracle Argus Basic Cloud Service,

Base.


The Service Level Targets for this Oracle Cloud Service are provided with the Oracle Argus Basic

Cloud Service, Base.




Oracle Argus Basic Cloud Service, Additional Non-Production Environment –

Instance

Part #: B93360


Oracle Argus Basic Cloud Service, Additional Non-Production Environment is provided for the

following modules:

Oracle Argus Basic Cloud Service



Usage Limits



Limited to use for Your Oracle Argus Basic Cloud Service.


ordered.



The maintenance or upgrade schedule for the Additional Non-Production Environment is

the same as the schedule for Your Oracle Argus Basic Cloud Service.



Availability, are not applicable to the Additional Non-Production Environment.






RETIRED OFFERINGS

DEFINITIONS FOR RETIRED OFFERINGS

Case

Case is defined as a safety concept identified by a case ID number and which contains data elements

related to the safety of a product. If the total number of Cases created (including E2B, Deleted, and

Literature cases) in any Oracle Argus Cloud Service in any 12-month period following the Cloud

Services Start Date exceed the number purchased, then additional Cases must be purchased.

Migrated cases are excluded.

SERVICE DESCRIPTIONS FOR RETIRED OFFERINGS

Oracle Argus Enterprise Edition Cloud Service – Case

Part #: B73043


Users of the Oracle Argus Enterprise Edition Cloud Service are authorized to access the following

modules:

Oracle Argus Safety




Oracle Argus Insight

Oracle Argus Analytics

Oracle Argus Mart

Oracle B2B

Usage Limits


The quantity of Cases defined in your order.

A combined maximum of 500,000 Cases and Japan Cases. If You require more than 500,000

then You may need to place an additional order for Oracle Argus Enterprise Edition Cloud

Service.

Oracle will provision one Production Environment and two Non-Production Environments

(Test and Development) for this Cloud Service.

The Cloud Service provides 2 node RAC database and web servers. These are load balanced to

provide a high availability solution in the event of a failure on the primary servers.

Up to 5 terabytes of database storage per database instance.





OBJECTIVE (RTO)

RECOVERY POINT

OBJECTIVE (RPO)

TARGET SYSTEM

AVAILABILITY

Oracle Argus Enterprise Edition Cloud

Service * 30 to 90 days 48 Hours 99.5%


Availability does not apply in the event of a declared disaster. For the purposes of this Cloud Service,

the Service Level Targets above take precedence over anything to the contrary in the Oracle Cloud

Policies.

* If You have purchased Oracle Argus Enhanced Disaster Recovery Cloud Service then the Service Level

Targets for Oracle Argus Enhanced Disaster Recovery Cloud Service apply to this Cloud Service.


Oracle Argus Interchange module, used with an electronic gateway, enables electronic submissions and

exchanges. The Oracle B2B gateway is supported as an option for the electronic gateway. Oracle Argus

Interchange module can also be used along with Axway B2Bi for electronic submission. Axway B2Bi is

required as the electronic gateway for Partition Mode, as described below. The permitted exchange

protocols are AS1 and AS2 with message encryption and/or HTTPS-enabled transmission. For AS1

communication, configuration of IMAP/POP3 is supported using SMTP over VPN.

For Oracle to provide the Oracle Argus Cloud Service, You are required to obtain the necessary licenses

to any of the following third party software You will use:

Axway B2Bi 2.6 SP1

JDrug


Microsoft Office


WHO Drug Dictionary




Argus Cloud Service, fax via email using Your fax as the end point. Fax status tracking and fax

responses are not available in Oracle Argus Cloud Service.

For any required third party software You will use, You must purchase a license, as well as all consents,

permits, and authorizations necessary for Oracle to access and use this software on Your behalf directly

from such third parties as part of this offering. You must provide evidence of such licenses prior to

Oracle’s installation of such, as well as a copy of the licensed software if applicable, and You are

responsible for supporting such software (including the purchase of support contracts from the third

party vendors as applicable).

For Axway B2Bi, You must provide Oracle with Your Axway “Support Identifier”. You will permit Oracle

to use your Axway Support Identifier to file service requests with Axway. You will provide the assistance

necessary for Oracle to pursue and escalate any issues and requests with Axway as needed to attempt

to resolve issues impacting Your ability to use the Services; however, You are ultimately responsible for

support of the Axway software.




1. To use MedDRA within the Oracle Argus Cloud Service, You will work with Oracle to establish

the necessary private circuit or VPN solution to facilitate secure web service communications

between the Oracle servers and Your network. You will be required to have an authentication

mechanism in place to secure the web service communication.

2. To use the SMTP capabilities from within the Argus Cloud Service, You must host within Your

network the required SMTP server necessary for these capabilities, and the SMTP service must

be accessible to the Oracle servers over a private circuit or VPN line.

3. Any digital certificates provided by You to Oracle for the purpose of system integrations must

be issued by a commercial certificate authority.




Customer-specific migration services required for transformation of Your data to Oracle data

models


Use of Utilities:








Production Environment(s), deploy the customizations or extensions in Your Production Environment

in accordance with Your Installation Documentation.




Develop Your own customizations or extensions using the Argus Cloud Extensibility and Integrations

Utility in accordance with Oracle’s extensibility guidelines, which are available at support.oracle.com

(Doc ID 2399180.1). You are responsible for the quality of Your customization or extension code and

ensuring that secure coding practices are followed.

Submit to Oracle change management requests to add customizations or extensions to Your Non-

Production and Production Environments, which must include:







Review and validate customizations or extensions in Your Non-Production Environment(s) before the

customizations or extensions may be deployed in Your Production Environment and, upon request by

Oracle, confirm within 30 calendar days that You have validated Your customizations or extensions

and that they may be deployed in Your Production Environment.



o Validating and resolving issues related to any impacts of maintenance or change management

(including but not limited to patches, upgrades, or new releases) on Your customizations or

extensions.

o Changes to customizations and extensions to ensure compatibility with the Cloud Services.





The Services are subject to the Oracle Cloud Hosting and Delivery Policies and Oracle Global Business

Unit Cloud Services Pillar Document, which may be viewed at www.oracle.com/contracts.

Oracle Argus Safety Japan Enterprise Edition Cloud Service – Case

Part #: B89666


Users of the Oracle Argus Safety Japan Enterprise Edition Cloud Service are authorized to access the

following modules:


Usage Limits



A combined maximum of 500,000 Cases and Japan Cases. If You require more than 500,000

then You may need to place an additional order for Oracle Argus Safety Japan Enterprise Edition

Cloud Service.

One Argus Enterprise Edition Cloud Service Case is required for each Oracle Argus Safety

Japan Enterprise Edition Cloud Service Case.

For the purposes of Oracle Argus Safety Japan Enterprise Edition Cloud Service, a Case

includes PMDA (Pharmaceuticals and Medical Devices Agency) information using Japanese

data items. Cases that do not contain PMDA information or Japanese data items are not

considered Cases for the purposes of this Cloud Service. Japanese data (also known as PMDA

data) is supported on case forms, including data items such as reporter, products, and

licenses.





This Cloud Service provides 2 node RAC database and web servers. These are load balanced to






OBJECTIVE (RTO)

RECOVERY POINT

OBJECTIVE (RPO)

TARGET SYSTEM

AVAILABILITY

Oracle Argus Safety Japan Enterprise

Edition Cloud Service * 30 to 90 days 48 Hours 99.5%




Policies.






Oracle Argus Enterprise Edition Enhanced Disaster Recovery Cloud Service – Case

Part #: B89667, B73048-Retired SKU


Oracle Argus Enterprise Edition Enhanced Disaster Recovery Cloud Service is provided for the following

modules that You have purchased:

Oracle Argus Enterprise Edition Cloud Service

Oracle Argus Safety Japan Enterprise Edition Cloud Service

Usage Limits

The Oracle Argus Enterprise Edition Enhanced Disaster Recovery Cloud Service is subject to usage

limits based on:


Oracle will provision one (1) Production Environment for this Cloud Service.






OBJECTIVE (RTO)

RECOVERY POINT

OBJECTIVE (RPO)

TARGET SYSTEM

AVAILABILITY

Oracle Argus Enterprise Edition Enhanced

Disaster Recovery Cloud Service * 24 Hours 1 Hour 99.5%

*Excluding periods of bulk load.

For the purposes of this Cloud Service, the Service Level Targets above take precedence over anything to the

contrary in the Oracle Cloud Policies.




Oracle Argus Enterprise Edition Cloud Service Additional Non-Production Environment

– Instance

Part #: B89668


Oracle Argus Enterprise Edition Cloud Service Additional Non-Production Environment is provided for

the following modules:


Usage Limits



Limited to use for Your Oracle Argus Enterprise Edition Cloud Service.

Oracle will provision one (1) Non-Production Environment for each Instance you have ordered.



The maintenance or upgrade schedule for the Additional Non-Production Environment is the

same as the schedule for Your Production Environment.



Availability, are not applicable to the Additional Non-Production Environment. Disaster Recovery is not

available for the Additional Non-Production Environment.







Oracle Argus Enterprise Edition Data Replication Cloud Service – Instance

Part #: B92876


Oracle Argus Enterprise Edition Data Replication Cloud Service is provided for the following modules

that You have purchased:



Oracle Argus Enterprise Edition Enhanced Disaster Recovery Cloud Service

Setup

Setup includes configuration of and initial load of data into the source database for the Cloud Service.

Usage Limits




The maintenance or upgrade schedule for the Oracle Argus Enterprise Edition Data Replication

Environment is the same as the schedule for Your Production Environment.




OBJECTIVE (RTO)

RECOVERY POINT

OBJECTIVE (RPO)

TARGET SYSTEM

AVAILABILITY

Oracle Argus Enterprise Edition Data

Replication Cloud Service * 30 to 90 days 48 Hours 99.5%




Policies.








Oracle Argus Enterprise Edition Data Replication Cloud Service Additional Non-

Production Environment – Instance

Part #: B92877


Oracle Argus Enterprise Edition Data Replication Cloud Service Additional Non-Production

Environment provided for the following modules that You have purchased:



Setup


Usage Limits



Oracle will provision one (1) Non-Production Environment for each Instance You have ordered.

The maintenance or upgrade schedule for the Oracle Argus Enterprise Edition Data Replication

Environment is the same as the schedule for Your Production Environment.








Oracle Argus Standard Edition Cloud Service – Case

Part #: B73042


Users of Oracle Argus Standard Edition Cloud Service are authorized to use the following modules:

Oracle Argus Safety




Oracle B2B



Usage Limits



A combined maximum of 20,000 Cases and Japan Cases during the Services Period (including

the quantity purchased on the initial order and any subsequent orders expanding the

quantity). If You require more than 20,000 then You must place a separate order for Oracle

Argus Enterprise Edition Cloud Service.



The Cloud Service provides 2 node RAC database and web servers. These are load balanced to






OBJECTIVE (RTO)

RECOVERY POINT

OBJECTIVE (RPO)

TARGET SYSTEM

AVAILABILITY

Oracle Argus Standard Edition Cloud

Service * 30 to 90 days 48 Hours 99.5%




Policies.




Oracle Argus Interchange module, used with an electronic gateway, enables electronic submissions and

exchanges. The Oracle B2B gateway is supported as an option for the electronic gateway. Oracle Argus

Interchange module can also be used along with Axway B2Bi for electronic submission. Axway B2Bi is

required as the electronic gateway for Partition Mode, as described below. The permitted exchange

protocols are AS1 and AS2 with message encryption and/or HTTPS-enabled transmission. For AS1

communication, configuration of IMAP/POP3 is supported using SMTP over VPN.

For Oracle to provide the Oracle Argus Cloud Service, You are required to obtain the necessary licenses

to any of the following third party software You will use:

Axway B2Bi 2.6 SP1

JDrug


Microsoft Office


WHO Drug Dictionary





Argus Cloud Service, fax via email using Your fax as the end point. Fax status tracking and fax

responses are not available in Oracle Argus Cloud Service.

For any required third party software You will use, You must purchase a license, as well as all consents,

permits, and authorizations necessary for Oracle to access and use this software on Your behalf directly

from such third parties as part of this offering. You must provide evidence of such licenses prior to

Oracle’s installation of such, as well as a copy of the licensed software if applicable, and You are

responsible for supporting such software (including the purchase of support contracts from the third

party vendors as applicable).

For Axway B2Bi, You must provide Oracle with Your Axway “Support Identifier”. You will permit Oracle

to use your Axway Support Identifier to file service requests with Axway. You will provide the assistance

necessary for Oracle to pursue and escalate any issues and requests with Axway as needed to attempt

to resolve issues impacting Your ability to use the Services; however, You are ultimately responsible for

support of the Axway software.



1. To use MedDRA within the Oracle Argus Cloud Service, You will work with Oracle to establish

the necessary private circuit or VPN solution to facilitate secure web service communications

between the Oracle servers and Your network. You will be required to have an authentication

mechanism in place to secure the web service communication.

2. To use the SMTP capabilities from within the Argus Cloud Service, You must host within Your

network the required SMTP server necessary for these capabilities, and the SMTP service must

be accessible to the Oracle servers over a private circuit or VPN line.

3. Any digital certificates provided by You to Oracle for the purpose of system integrations must

be issued by a commercial certificate authority.





models


Use of Utilities:









Production Environment(s), deploy the customizations or extensions in Your Production Environment

in accordance with Your Installation Documentation.




Develop Your own customizations or extensions using the Argus Cloud Extensibility and Integrations

Utility in accordance with Oracle’s extensibility guidelines, which are available at support.oracle.com

(Doc ID 2399180.1). You are responsible for the quality of Your customization or extension code and

ensuring that secure coding practices are followed.

Submit to Oracle change management requests to add customizations or extensions to Your Non-

Production and Production Environments, which must include:






Review and validate customizations or extensions in Your Non-Production Environment(s) before the

customizations or extensions may be deployed in Your Production Environment and, upon request by

Oracle, confirm within 30 calendar days that You have validated Your customizations or extensions

and that they may be deployed in Your Production Environment.



o Validating and resolving issues related to any impacts of maintenance or change management

(including but not limited to patches, upgrades, or new releases) on Your customizations or

extensions.

o Changes to customizations and extensions to ensure compatibility with the Cloud Services.







Oracle Argus Safety Japan Standard Edition Cloud Service – Case

Part #: B89663


Users of the Oracle Argus Safety Japan Standard Edition Cloud Service are authorized to access the

following modules:




Usage Limits



A maximum of 20,000 Cases and Japan Cases during the Services Period (including the

quantity purchased on the initial order and any subsequent orders expanding the quantity). If

You require more than 20,000 then You may need to place a separate order for Oracle Argus

Safety Japan Enterprise Edition Cloud Service.

One Argus Standard Edition Cloud Service Case is required for each Oracle Argus Safety

Japan Standard Edition Cloud Service Case.

For the purposes of Oracle Argus Safety Japan Standard Edition Cloud Service, a Case

includes PMDA (Pharmaceuticals and Medical Devices Agency) information using Japanese

data items. Cases that do not contain PMDA information or Japanese data items are not

considered Cases for the purposes of this Cloud Service. Japanese data (also known as PMDA

data) is supported on case forms, including data items such as reporter, products, and

licenses.



This Cloud Service provides 2 node RAC database and web servers. These are load balanced to






OBJECTIVE (RTO)

RECOVERY POINT

OBJECTIVE (RPO)

TARGET SYSTEM

AVAILABILITY

Oracle Argus Safety Japan Standard

Edition Cloud Service * 30 to 90 days 48 Hours 99.5%




Policies.








Oracle Argus Standard Edition Enhanced Disaster Recovery Cloud Service – Case

Part #: B89664, B73047-Retired SKU


Oracle Argus Standard Edition Enhanced Disaster Recovery Cloud Service is provided for the following

modules that You have purchased:

Oracle Argus Standard Edition Cloud Service

Oracle Argus Safety Japan Standard Edition Cloud Service

Usage Limits

The Oracle Argus Standard Edition Enhanced Disaster Recovery Cloud Service is subject to usage limits

based on:


Oracle will provision one (1) Production Environment for this Cloud Service.




OBJECTIVE (RTO)

RECOVERY POINT

OBJECTIVE (RPO)

TARGET SYSTEM

AVAILABILITY

Oracle Argus Standard Edition Enhanced

Disaster Recovery Cloud Service * 24 Hours 1 Hour 99.5%


For the purposes of this Cloud Service, the Service Level Targets above take precedence over anything to the

contrary in the Oracle Cloud Policies.




Oracle Argus Standard Edition Cloud Service Additional Non-Production Environment –

Instance

Part #: B89665


Oracle Argus Standard Edition Cloud Service Additional Non-Production Environment is provided for

the following modules:


Usage Limits





Limited to use for Your Oracle Argus Standard Edition Cloud Service.

Oracle will provision one (1) Non-Production Environment for each Instance you have ordered.



The maintenance or upgrade schedule for the Additional Non-Production Environment is the

same as the schedule for Your Production Environment.








Oracle Argus Standard Edition Data Replication Cloud Service – Instance

Part #: B92874


Oracle Argus Standard Edition Data Replication Cloud Service provided for the following modules that

You have purchased:



Oracle Argus Standard Edition Enhanced Disaster Recovery Cloud Service

Setup


Usage Limits




The maintenance or upgrade schedule for the Oracle Argus Standard Edition Data Replication

Cloud Service is the same as the schedule for Your Production Environment.






OBJECTIVE (RTO)

RECOVERY POINT

OBJECTIVE (RPO)

TARGET SYSTEM

AVAILABILITY

Oracle Argus Standard Edition Data

Replication Cloud Service * 30 to 90 days 48 Hours 99.5%




Policies.






Oracle Argus Standard Edition Data Replication Cloud Service Additional Non-

Production Environment – Instance

Part #: B92875


Oracle Argus Standard Edition Data Replication Cloud Service Additional Non-Production Environment

provided for the following modules You have purchased:



Setup


Usage Limits


The quantity of Instances defined in your order

Oracle will provision one (1) Non-Production Environment for each Instance You have ordered.

The maintenance or upgrade schedule for the Oracle Argus Standard Edition Data Replication

Additional Non-Production Environment is the same as the schedule for Your Production

Environment.










Oracle Argus Cloud Service Additional Non-Production Environment – Instance

Part #: B84626

The Oracle Argus Cloud Service Additional Non-Production Environment provides for an additional

Non-Production Environment for use with Your Oracle Argus Cloud Service. Certain programs and

optional services may not be able to run in the Additional Non-Production Environment. The

maintenance or upgrade schedule for the Additional Non-Production Environment is the same as the

schedule for Your Production Environment.

Each Additional Non-Production Environment will automatically terminate at the end of the Service

Period of the associated Oracle Cloud Service. Performance metrics and service levels applicable to

Your Production Environment(s) are not applicable to the Additional Non-Production Environment.

Disaster Recovery is not available in the Additional Non-Production Environment.

Usage Limits: The Oracle Argus Cloud Service Additional Non-Production Environment is

subject to usage limits based on:

A maximum number of authorized Instances as defined in your order

Oracle will provision one (1) Non-Production Environment for the quantity of Instances as

defined in your order.




Oracle Argus Cloud Service Enhanced Disaster Recovery – Instance

Part #: B86411

Usage Limits: The Oracle Argus Cloud Service Enhanced Disaster Recovery is subject to usage

limits based on:

A maximum number of authorized Cases as defined in your order.

Oracle will provision one (1) Production Environment for the number of Cases defined in your

order.

Service Level Targets: The Cloud Service has the following service level targets:


OBJECTIVE (RTO)

RECOVERY POINT

OBJECTIVE (RPO)

TARGET SYSTEM

AVAILABILITY

Oracle Argus Cloud Service Enhanced

Disaster Recovery* 24 Hours 1 Hour 99.5%





For the purposes of this Cloud Service, the Service Level Targets above take precedence over anything

to the contrary in the Oracle Cloud Policies.


implement, test and deploy:



models





Oracle Argus Safety Japan Cloud Service – Case

Part #: B73044

Usage Limits: The Oracle Argus Safety Japan Cloud Service is subject to usage limits based on:

A maximum number of authorized Cases as defined in your order.



The following usage limits apply:

METRIC DATABASE STORAGE (TB) FILE STORAGE (GB) BANDWIDTH

500 - 500,000 Cases* up to 5 terabytes per

database instance N/A N/A

The Oracle Argus Safety Japan Cloud Service provides 2 node RAC database and web servers. These

are load balanced to provide a high availability solution in the event of a failure on the primary servers.

*If You require more than 500,000 Cases of Oracle Argus Safety Japan Cloud Service then You may

need to place an additional order for Oracle Argus Safety Japan Cloud Service

Production Service Level Targets: The Cloud Service has the following service level targets:


OBJECTIVE (RTO)

RECOVERY POINT

OBJECTIVE (RPO)

TARGET SYSTEM

AVAILABILITY

Oracle Argus Safety Japan Cloud Service 30 to 90 days 48 Hours 99.5%






Policies.




oracle argus cloud services service descriptions and metrics

Documents